WHAT 'IS' A MEDICAL DEVICE?
Any product designated as a Medical Device has to have EC certification and is regulated by competent authorities in each country -in the UK this is the ‘Medicines and Healthcare Products Regulatory Agency’. This means that the product has undergone extensive clinical studies to verify the product’s effectiveness and safety.
All claims and effectiveness reported by the manufacturer must be validated by the relevant authorities and audited regularly to make sure that the product complies.
Therefore, this should in fact re-assure purchasers and users of these products because it means that the product meets all the stated performance and safety criteria such as rigorous testing, verified results, and that “it does what it says on the tin”.
Some common forms of Medical Devices range from simple tongue depressors and thermometers to complex implants, pacemakers, surgical instruments, etc.
It must be noted that a Medical Device is not a medicine -medicinal products have a pharmacological action in that they enter our bodies and change the way our bodies function. Medical Devices generally work by a physical or mechanical action and do not alter the chemical functions in our body.
All Medical Devices must be approved by the relevant authorities and they will be issued with a CE Mark which must be displayed on the product.
Our Medical Device “Limitless” has gone through extensive clinical studies to validate it’s effectiveness and safety when used for weight management. Our CE Mark number is 1370.
“Limitless” is made of a patented complex of 100% plant fibres in a vegetarian friendly capsule. These fibres do not enter the body; they remain in the intestine and are eliminated in your stools. These fibres have physico-chemical characteristics and function by absorbing fats and sugars in your gut. The dynamic fibre complex acts mechanically by forming a mesh that collects and entraps sugars and fats and prevents your body from absorbing them. There is no pharmacological action because the fibres do not enter your blood system. This fibre complex and the entrapped fats and sugars are then eliminated via the intestinal transit in your stools.
“Limitless” works by capturing excess calories from the food you eat and helps you manage your weight with no side effects.
“Limitless” has been thoroughly tested, it works and it is safe.
To find out more about the science click here.
Papa Scriv -"THE CHEMIST"